Implantable medical device characterization system

US 5,423,334 A
Filed: 02/01/1993
Issued: 06/13/1995
Est. Priority Date: 02/01/1993
Status: Expired due to Fees

First Claim

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1. A system for permitting the acquisition from outside the body of a patient of data pertaining to medical devices implanted therein, the system comprising:

(a) a medical device capable of subcutaneous implantation at a predetermined implant location in the body of the patient;

(b) a medical device data circuit secured to said medical device prior to the implantation thereof, said data circuit being powered by energy absorbed through the mutual inductive coupling thereof with an alternating magnetic field generated external to the body of the patient, said data circuit comprising;

(i) field detection means for inductively coupling with said alternating magnetic field, and responsive thereto for generating a data circuit signal; and

(ii) coding means electrically coupled to said field detection means for selectively loading and unloading said field detection means in a predetermined sequence of loading conditions responsive to said data circuit signal, said sequence of loading conditions corresponding to data pertaining to said medical device, and said loading and unloading of said field detection means correspondingly varying the amount of said energy absorbed from said alternating magnetic field in generating said data circuit signal; and

(c) a medical device characterization probe movable external to the body of the patient in the vicinity of said implant location, said identification probe comprising;

(i) field generation means coupleable to a source of alternating electric power for generating said alternating magnetic field; and

(ii) sensor means electrically coupled to said field generation means for producing a probe signal reflecting variations in said amount of said energy absorbed from said alternating magnetic field by said data circuit.

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Abstract

A system for enabling the acquisition from outside the body of a patient of data pertaining to a medical device implanted therein. A characterization tag is secured to the medical device prior to the implantation thereof. The characterization tag is powered by energy absorbed through the mutual inductive coupling of circuitry in the characterization tag with an alternating magnetic field generated outside the body of the patient. That circuitry in the characterization tag is selectively loaded and unloaded in a predetermined sequence of loading conditions that correspond to data about the implanted medical device. The alternating magnetic field is generated in a characterization probe, moveable external to the body of the patient. The probe includes electrical circuitry for sensing variations in the amount of energy absorbed from the field by the characterization tag. The characterization tag is secured to the exterior of the medical device by a biocompatible potting material in a characterization tag recess or, if the medical device is assembled from a plurality of constituent parts, by permanently capturing the characterization tag between a pair of these parts. Two single fluid reservoir access ports, a double fluid reservoir access port, a septum-less access port, and prosthetic hip joint are disclosed employing the system.

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44 Claims

1. A system for permitting the acquisition from outside the body of a patient of data pertaining to medical devices implanted therein, the system comprising:
- (a) a medical device capable of subcutaneous implantation at a predetermined implant location in the body of the patient;
  
  (b) a medical device data circuit secured to said medical device prior to the implantation thereof, said data circuit being powered by energy absorbed through the mutual inductive coupling thereof with an alternating magnetic field generated external to the body of the patient, said data circuit comprising;
  
  (i) field detection means for inductively coupling with said alternating magnetic field, and responsive thereto for generating a data circuit signal; and
  
  (ii) coding means electrically coupled to said field detection means for selectively loading and unloading said field detection means in a predetermined sequence of loading conditions responsive to said data circuit signal, said sequence of loading conditions corresponding to data pertaining to said medical device, and said loading and unloading of said field detection means correspondingly varying the amount of said energy absorbed from said alternating magnetic field in generating said data circuit signal; and
  
  (c) a medical device characterization probe movable external to the body of the patient in the vicinity of said implant location, said identification probe comprising;
  
  (i) field generation means coupleable to a source of alternating electric power for generating said alternating magnetic field; and
  
  (ii) sensor means electrically coupled to said field generation means for producing a probe signal reflecting variations in said amount of said energy absorbed from said alternating magnetic field by said data circuit.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
- - 2. A system as recited in claim 1, wherein said characterization probe further comprises digital decoding means electrically coupled to said sensor means for processing said probe signal to produce a digital data signal corresponding to said variations in said amount of said energy absorbed from said alternating magnetic field by said data circuit and for correlating said digital data signal with said data pertaining to said medical device.
  - 3. A system as recited in claim 2, wherein said characterization probe further comprises display means electrically coupled to said digital decoding means for giving a visual indication of said data pertaining to said medical device.
  - 4. A system as recited in claim 1, wherein said coding means comprises:
    - (a) article characterization means for storing data pertaining to said medical device and for reading out said data in a timed sequence by loading said field detection means in said predetermined sequence of loading conditions; and
      
      (b) timer means electrically coupled between said field detection means and said article characterization means for driving said article characterization means to read out said data in response to said data circuit signal.
  - 5. A system as recited in claim 4, wherein said article characterization means comprises:
    - (a) an electrical load;
      
      (b) a switching circuit for selectively coupling and uncoupling said load to said field detection means; and
      
      (c) a memory means coupled to said switching circuit for storing said data pertaining to said medical device and for reading out said data by driving said switching circuit in a timed sequence corresponding to said data.
  - 6. A system as recited in claim 5, wherein said timing means comprises a timer circuit coupled between said field detection means and said memory means, said timer circuit being activated by said data circuit signal to drive said memory means to read out said data.
  - 7. A system as recited in claim 1, wherein said medical device comprises an implantable access port.
  - 8. A system as recited in claim 7, wherein said implantable access port comprises a needle-impenetrable housing enclosing a first fluid cavity and defining a first access aperture through said housing communicating with said first fluid cavity.
  - 9. A system as recited in claim 8, wherein a data circuit recess is formed on the exterior of said housing, and said data circuit is disposed in said data circuit recess.
  - 10. A system as recited in claim 9, wherein said data circuit is retained in said data circuit recess by a biocompatible potting material.
  - 11. A system as recited in claim 8, wherein said housing comprises:
    - (a) a generally planar floor;
      
      (b) a top wall disposed opposite said floor generally parallel thereto, said first access aperture being formed through said top wall of said housing;
      
      (c) side walls extending from the periphery of said floor to the periphery of said top wall; and
      
      (d) a needle-penetrable material encasing the exterior of said floor of said housing and the exterior of portions of said side walls adjacent thereto.
  - 12. A system as recited in claim 11, wherein said data circuit is disposed against said exterior of said floor between said housing and said needle-penetrable material.
  - 13. A system as recited in claim 11, wherein said data circuit is disposed against the exterior of one of said side walls between said housing and said needle-penetrable material.
  - 14. A system as recited in claim 8, wherein said housing comprises a plurality of components, and wherein said data circuit is permanently captured between a pair of said components.
  - 15. A system as recited in claim 8, wherein said housing comprises:
    - (a) a base having a flat floor and walls normal to an upstanding therefrom, said walls defining said first fluid cavity; and
      
      (b) a cap configured to receive said base, said cap comprising;
      
      (i) a top wall having formed therein said first access aperture at a position opposite said first fluid cavity when said base is received in said cap; and
      
      (ii) a skirt depending from the periphery of said top wall, said skirt enclosing said walls of said base when said cap is received in said base.
  - 16. A system as recited in claim 15, wherein a data circuit recess is formed in a surface of said base contacted by said cap when said base is received in said cap, and wherein said data circuit is disposed in said data circuit recess prior to said base being received in said cap.
  - 17. A system as recited in claim 15, wherein a data circuit recess is formed in a surface of said cap contacted by said base when said base is received in said cap, and wherein said data circuit is disposed in said data circuit recess prior to said base being received in said cap.
  - 18. A system as recited in claim 8, wherein said implantable access port further comprises a needle-penetrable septum captured by said housing and sealing said first access aperture.
  - 19. A system as recited in claim 8, wherein said implantable access port comprises:
    - (a) a needle-impenetrable housing enclosing and defining the following;
      
      (i) a valve chamber;
      
      (ii) an outlet passageway communicating between said valve chamber and the exterior of said housing;
      
      (iii) a non-linear entry passageway communicating at the distal end thereof with said valve chamber and at the proximal end thereof with the exterior of said housing; and
      
      (iv) a funnel-shaped entrance orifice formed in the surface of said housing communicating at the narrow end thereof with said proximal end of said entry passageway; and
      
      (b) a leaflet valve captured in said valve chamber by said housing, thereby to provide a selectively-openable fluid seal between said entry passageway and said outlet passageway.
  - 20. A system as recited in claim 8, wherein said housing further encloses a second fluid cavity and defines a second access aperture communicating through said housing with said second fluid cavity.
  - 21. A system as recited in claim 20, wherein a data circuit recess is formed on the exterior of said housing, and said data circuit is disposed in said data circuit recess.
  - 22. A system as recited in claim 21, wherein said data circuit is retained in said data circuit recess by a biocompatible potting material.
  - 23. A system as recited in claim 20, wherein said housing comprises:
    - (a) a generally planar floor;
      
      (b) a top wall disposed opposite said floor generally parallel thereto, said first access aperture and said second access aperture being formed through said top wall of said housing;
      
      (c) side walls extending from the periphery of said floor to the periphery of said top wall;
      
      (d) an inner wall extending between said floor, said top wall, and opposed portions of said side walls, thereby to define on opposite sides of said inner wall said first fluid cavity and said second fluid cavity, respectively.
  - 24. A system as recited in claim 20, wherein said housing comprises a plurality of components, and wherein said data circuit is permanently captured between a pair of said components.
  - 25. A system as recited in claim 20, wherein said housing comprises:
    - (a) a base having a flat floor and walls normal to and upstanding therefrom, said walls defining said first fluid cavity and said second fluid cavity;
      
      (b) a planar septum support configured to mate with the ends of said walls of said base opposite said floor of said base, said septum support having formed therethrough a first septum receiving aperture positioned above said lo first fluid cavity and a second septum receiving aperture position above said second fluid cavity; and
      
      (c) a cap configured to receive said septum support and said base, said cap comprising;
      
      (i) a top wall having formed therein a first septum access aperture at a position opposite said first septum receiving aperture when said septum support and said base are received in said cap and a second access aperture at a position opposite said second septum receiving aperture when said septum support and said base are received in said cap; and
      
      (ii) a skirt depending from the periphery of said top wall of said cap, said skirt enclosing said septum support and said walls of said base when said septum support and said base are received in said cap.
  - 26. A system as recited in claim 25, wherein a data circuit recess is formed in a surface of said base contacted by said septum support when said septum support mates with said ends of said walls of said base opposite from said floor of said base, and wherein said data circuit is disposed in said data circuit recess prior to the mating of said septum support with said ends of said walls of said base.
  - 27. A system as recited in claim 25, wherein a data circuit recess is formed in a surface of said septum support contacted by said cap when said base and said septum support are received in said cap, and wherein said data circuit is disposed in said data circuit recess prior to said base and said septum support being received in said cap.
  - 28. A system as recited in claim 25, wherein a data circuit recess is formed in a surface of said base contacted by said cap when said base and said septum support are received in said cap, and wherein said data circuit is disposed in said data circuit recess prior to said base and said septum support being received in said cap.
  - 29. A system as recited in claim 20, wherein said implantable access port further comprises:
    - (a) a first needle-penetrable septum captured by said housing and sealing said first access aperture; and
      
      (b) a second needle-penetrable septum captured by said housing and sealing said second access aperture.
  - 30. A system as recited in claim 1, wherein said field detection means comprises an induction coil secured to said medical device and electrically coupled to said coding means.
  - 31. A system as recited in claim 1, wherein said field generation means comprises an induction coil housed in said characterization probe and electrically coupled to said sensor means.
  - 32. A system as recited in claim 1, wherein said field generation means comprises a first resonant circuit housed in said identification probe and comprising components defining a first resonant frequency associated therewith, said first resonant circuit comprising:
    - (a) a first induction coil housed in said characterization probe and being electrically coupled to said sensor means; and
      
      (b) a first capacitor connected in parallel to said first induction coil.
  - 33. A system as recited in claim 32, wherein said first induction coil comprises:
    - (a) a core; and
      
      (b) a conductor wrapped said core.
  - 34. A system as recited in claim 33, wherein said core is comprised of a ferrous material.
  - 35. A system as recited in claim 33, wherein said core assumes a generally elongate shape having a longitudinal axis, and said longitudinal axis is oriented toward the skin of the patient when said characterization probe is moved external to the body of the patient in the vicinity of said implant location.
  - 36. A system as recited in claim 33, wherein said core is generally C-shaped.
  - 37. A system as recited in claim 33, wherein said core terminates in first and second non-parallel, flat, flux-transmitting surfaces, said first and second flux-transmitting surfaces defining corresponding first and second flux-transmitting planes, said first and second flux-transmitting planes forming a dihedral angle the interior of which is oriented toward the skin of the patient when said characterization probe is moved external to the body of the patient in the vicinity of said implant location.
  - 38. A system as recited in claim 32, wherein said field detection means comprises a second resonant circuit secured to said medical device and comprising components defining a second resonant frequency associated therewith, said second resonant circuit comprising:
    - (a) a second induction coil secured to said medical device and being electrically coupled to said coding means; and
      
      (b) a second capacitor connected in parallel to said second induction coil.
  - 39. A system as recited in claim 38, wherein said second resonant frequency is substantially equal to said first resonant frequency.
  - 40. A system as recited in claim 1, wherein said medical device comprises an implantable prosthetic article.
  - 41. A system as recited in claim 40, wherein said prosthetic article comprises a hip joint transplant.
  - 42. A system as recited in claim 41, wherein said hip joint transplant comprises:
    - (a) a shaft having first and second ends, said first end of said shaft being attachable to the femur of the patient, and said second end of said shaft terminating in a spherical portion; and
      
      (b) a cup portion attachable to the hip bone of the patient, said cup portion being so configured on the side thereof opposite the hip bone of the patient as to pivotably receive said spherical portion of said shaft in a ball-and-socket relationship.
  - 43. A system as recited in claim 42, wherein a data circuit recess is formed on the exterior of said shaft of said hip joint transplant, and said data circuit is disposed in said data circuit recess.
  - 44. A system as recited in claim 43, wherein said data circuit is retained in said data circuit recess by a biocompatible potting material.

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Current Assignee
C.R. Bard, Inc. (Becton, Dickinson & Co)
Original Assignee
C.R. Bard, Inc. (Becton, Dickinson & Co)
Inventors
Jordan, Guy J.
Primary Examiner(s)
Sykes, Angela D.

Application Number

US08/012,541
Time in Patent Office

862 Days
Field of Search

128/668, 128/897-898, 128/899, 128/903, 128/748, 128/673, 128/653.4, 607/30-34, 607/60, 607/27, 623/11, 623/24
US Class Current

128/899
CPC Class Codes

A61B 2562/08   Sensors provided with means...

A61B 5/0031   Implanted circuitry

A61B 90/90   Identification means for pa...

A61B 90/98   using electromagnetic means...

A61F 2/32   for the hip

A61F 2/3609   Femoral heads or necks; Con...

A61F 2002/3067   for data transfer

A61F 2002/3071   Identification means; Admi...

A61F 2002/3611   Heads or epiphyseal parts o...

A61F 2002/3625   Necks

A61F 2002/3631   with an integral complete o...

A61F 2002/365   Connections of heads to necks

A61F 2002/4696   optical

A61F 2250/0002   for data transfer

A61F 2250/0085   Identification means; Admin...

A61M 2039/0211   with multiple chambers in a...

A61M 2039/0238   having means for locating t...

A61M 39/0208   Subcutaneous access sites f...

G06K 19/07777   the antenna being of the in...

G06K 7/0008   General problems related to...

Y10S 623/912 : Method or apparatus for mea...

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Implantable medical device characterization system

First Claim

1 Assignment

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Abstract

645 Citations

44 Claims

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Implantable medical device characterization system

First Claim

1 Assignment

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0 Petitions

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Accused Products

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Abstract

645 Citations

44 Claims

Specification

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Solutions

Use Cases

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